FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
'EXMOOR' ATKINS NASAL SPLINT
K Number: K864930
·
Decision Mar 4, 1987
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
14
Applicant Total
43
Review Days
78
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Basic Information
- Device Name
- 'EXMOOR' ATKINS NASAL SPLINT
- K Number
- K864930
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5800
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Exmoor Plastics , Ltd.
- Date Received
- December 16, 1986
- Decision Date
- March 4, 1987
- Product Code
- EPP
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EPP | Splint, Nasal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPP), ordered by most recent decision date.
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EXTERNAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HOOD NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AMERICAN NASAL SPONGE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Exmoor Plastics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K093863 | EPIDRUM | May 10, 2010 | Substantially Equivalent |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | Mar 5, 1999 | Substantially Equivalent |
| K980828 | EXMOOR MYRINGOTOMY KIT | Oct 22, 1998 | Substantially Equivalent |
| K981143 | DILKES LASER/SUCTION CANNULAE | Sep 14, 1998 | Substantially Equivalent |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) | Jul 16, 1998 | Substantially Equivalent |
| K981088 | MILLS COLUMELLA PROSTHESIS | Jun 5, 1998 | Substantially Equivalent |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | May 20, 1998 | Substantially Equivalent |
| K974008 | PFLEIDERER'S INTRATYMPANIC CATHETER | May 13, 1998 | Substantially Equivalent |
| K974224 | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | Jan 27, 1998 | Substantially Equivalent |
| K973587 | EXMOOR TYMPANOCENTESIS KIT (TK/1) | Jan 23, 1998 | Substantially Equivalent |